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PubMed1999

Losartan therapy for Raynaud's phenomenon and scleroderma: clinical and biochemical findings in a fifteen-week, randomized, parallel-group, controlled trial.

OBJECTIVE: To compare the efficacy and tolerability of losartan, an antagonist of angiotensin II receptor type 1, with nifedipine for the treatment of primary and secondary Raynaud's phenomenon (RP) in a pilot study. METHODS: In a randomized, parallel-group, controlled trial, patients with primary RP (n = 25) or RP secondary to systemic sclerosis (SSc [scleroderma]; n = 27) were allocated to receive 12 weeks' treatment with either losartan (50 mg/day) or nifedipine (40 mg/day). Primary outcome variables were the severity and frequency of RP episodes and findings on vascular measurements, including thermography and laser Doppler flowmetry. Serum levels of soluble adhesion molecules, endothelin 1, fibrinogen, von Willebrand factor, and procollagen type I N-terminal propeptide (PINP) were also measured. RESULTS: There was a reduction in the severity of RP episodes following treatment with losartan and with nifedipine, but this effect was greater in the losartan arm of the study (P<0.05): episode frequency was reduced only in the losartan group (P<0.01 versus baseline). Symptomatic improvement was associated with a significant reduction in soluble vascular cell adhesion molecule 1 and PINP (P<0.01). Subgroup analysis suggested that although these biochemical changes occurred mainly in SSc patients, the clinical benefit was greater in the primary RP group. CONCLUSION: This study confirms the tolerability of short-term treatment of RP with losartan, and our data suggest its clinical benefit. Further evaluation of this drug as a long-term treatment for SSc-associated RP should be considered, since it may have additional disease-modifying potential.

Adult↗
PubMed1978

[Alpha activity in a group of schizophrenics: spectral analysis and comparison with a control group (author's transl)].

Spectral analysis of tracings from four leads; C3-P3, P3-O1, C4-P4, and P4-O2, were used to compare the results of fiftyseven electroencephalograms from 10 schizophrenics, and 14 normal subjects used as controls. The results show that the mean frequencies of the alpha waves are identical in schizophrenics and controls. Patients with hebephrenia show the lowest variations in alpha wave frequency but with the highest voltage, whereas paranoid schizophrenics have tracings with the lowest amplitude and the greatest variation in frequency. There is also better left intrahemispheric correlation of relative alpha intensities in those patients with the lowest variation in right alpha intensity in relation to controls. The preliminary results suggest that there is a reduction in functional asymmetry of the hemispheres in the electroencephalograms from schizophrenics, when looking at the alpha activity.

Adult↗
PubMed1996

A study at 10 medical centers of the safety and efficacy of 48 flexible sigmoidoscopies and 8 colonoscopies during pregnancy with follow-up of fetal outcome and with comparison to control groups.

To analyze the risks versus benefits of flexible sigmoidoscopy and colonoscopy to the pregnant female and fetus, we conducted a multiyear, retrospective study at 10 hospitals of 46 patients undergoing 48 sigmoidoscopies and 8 patients undergoing 8 colonoscopies during pregnancy. Sigmoidoscopy controls included two study control groups and the average American pregnancy outcomes. Sigmoidoscopy indications included hematochezia in 28, diarrhea in 10, abdominal pain in 4, and other in 3. Thirteen patients were in the first trimester of pregnancy, 18 were in the second trimester, and 15 were in the third trimester. Twenty-seven patients had a lesion diagnosed by sigmoidoscopy, including reactivated or newly diagnosed inflammatory bowel disease, bleeding internal hemorrhoids, and other colitidies. Twenty-two of 29 patients with rectal bleeding had a significant lesion identified by sigmoidoscopy. Sigmoidoscopy was significantly more frequently diagnostic for hematochezia than for other indications (p < 0.03, chi2). No endoscopic complications occurred to the pregnant patients. Excluding 4 voluntary abortions and 1 unknown pregnancy outcome, 38 (93%) of 41 pregnant females delivered healthy babies (study control rate = 93%; NS, Fisher's exact test). Mean live-born infant Apgar scores were 8.2+/-1.5 (SD) at 1 min and 9.0+/-0.2 at 5 min (control mean Apgar scores: 8.1+/-1.7 at 1 min and 8.8+/-1.0 at 5 min; NS, Student's t test). Three high-risk pregnancies ended with fetal demise at 8, 9, or 12 weeks after sigmoidoscopy, from causes unrelated to sigmoidoscopy. No fetal cardiac abnormalities were detected by fetal cardiac monitoring during two sigmoidoscopies. Eight pregnant females underwent colonoscopy, without complications. Pregnancy outcomes included six healthy babies delivered at full term, one voluntary abortion, and one fetal demise in a high-risk pregnancy 4 months after colonoscopy from causes unrelated to colonoscopy. This study suggests that sigmoidoscopy does not induce labor or result in congenital malformations, that sigmoidoscopy is not contraindicated during pregnancy, and that sigmoidoscopy may be beneficial in pregnant patients with significant lower gastrointestinal bleeding. Colonoscopy during pregnancy should be considered for life-threatening lower gastrointestinal bleeding or when the only alternative is surgery.

Colonoscopy↗
PubMed2005

Reflux, dysphagia, and gas bloat after laparoscopic fundoplication in patients with incidentally discovered hiatal hernia and in a control group.

BACKGROUND: Laparoscopic fundoplication effectively controls reflux symptoms in patients with gastroesophageal reflux disease (GERD). However, symptom relapse and side effects, including dysphagia and gas bloat, may develop after surgery. The aim of the study was to assess these symptoms in patients who underwent laparoscopic fundoplication, as well as in control subjects and patients with hiatal hernia. METHODS: A standardized, validated questionnaire on reflux, dysphagia, and gas bloat was filled out by 115 patients with a follow-up of 1 to 7 years after laparoscopic fundoplication, as well as by 105 subjects with an incidentally discovered hiatal hernia and 238 control subjects. RESULTS: Patients who underwent fundoplication had better reflux scores than patients with hiatal hernia ( P = .0001) and similar scores to control subjects ( P = .11). They also had significantly more dysphagia and gas bloat than patients with hiatal hernia and controls ( P < .005 for all comparisons). Gas bloat and dysphagia were more severe in hiatal hernia patients than in controls ( P < 0.005). After fundoplication, the 25% of the patients with the shortest follow-up (1.5 +/- 0.2 years) and the 25% patients with the longest follow-up (5.8 +/- 0.6 years) had similar reflux, dysphagia, and gas bloat scores ( P = .43, .82, and .85, respectively). CONCLUSION: In patients with severe GERD, laparoscopic fundoplication decreases reflux symptoms to levels found in control subjects. These results appear to be stable over time. However, patients who underwent fundoplication experience more dysphagia and gas bloat than controls and patients with hiatal hernia-symptoms that should be seen as a side effect of the procedure and of GERD itself.

Adult↗
PubMed2001

Control group and maintenance treatment with bacillus Calmette-Guerin for carcinoma in situ and/or high grade bladder tumors.

PURPOSE: Intravesical instillations of bacillus Calmette-Guerin have demonstrated satisfactory results in the treatment of vesical carcinoma in situ and high grade superficial bladder tumors. We designed a protocol to evaluate the decrease in tumor recurrence with maintenance therapy. MATERIALS AND METHODS: Between June 1989 and May 1995 an initial course of 6 intravesical instillations of Connaught strain bacillus Calmette-Guerin was administered in patients with carcinoma in situ and/or high grade superficial bladder tumors. Six months later 131 disease-free patients were randomly assigned to a control group or a maintenance therapy group that received 6 instillations every 6 months (6 x 6) for a 2-year period. RESULTS: Of the 126 evaluable patients at a mean followup of 79 months there were no significant differences in recurrence nor progression. A total of 16 patients (26.2%) in the control and 10 (15.1%) in the maintenance group had superficial relapse at a mean of 24 and 20 months, respectively (p = 0.07). Eight patients underwent radical cystectomy due to bladder contraction in 1, high grade superficial recurrence in 4 and disease progression in 3. Of the 65 patients on maintenance therapy 22 (33.85%) completed the planned 2-year treatment. CONCLUSIONS: Six-month maintenance therapy in patients treated initially for carcinoma in situ and/or high grade superficial bladder tumors who are disease-free at 6 months did not significantly decrease recurrence or progression.

Adult↗
PubMed2004

Cementless metal-on-metal hip arthroplasty in patients less than 50 years of age: comparison with a matched control group using ceramic-on-polyethylene after a minimum 5-year follow-up.

Thirty-nine cementless hip arthroplasties using metal-on-metal articulation were consecutively implanted in 30 patients less than 50 years of age and compared with a matched control group (by age, diagnosis, Devane activity, and Harris hip scores) of cementless arthroplasties using ceramic-on-polyethylene articulation. The Harris hip score at follow-up (minimum 5 years) for the metal-on-metal was 94.9 (range, 74-100). After the same follow-up, the results of the ceramic-on-polyethylene were significantly worse: 9 osteolyses and 7 surgical revisions related to wear (none in the metal-on-metal). Five-year survival rates were 97% +/-2% for the ceramic-on-polyethylene and 100% for the metal-on-metal. The metal-on-metal may be recommended to prevent wear problems in younger and more active patients; however, a longer follow-up is required to confirm this encouraging data.

Adult↗
PubMed2006

Summary proceedings from the neonatal pain-control group.

Recent advances in neurobiology and clinical medicine have established that the fetus and newborn may experience acute, established, and chronic pain. They respond to such noxious stimuli by a series of complex biochemical, physiologic, and behavioral alterations. Studies have concluded that controlling pain experience is beneficial with respect to short-term and perhaps long-term outcomes. Yet, pain-control measures are adopted infrequently because of unresolved scientific issues and lack of appreciation for the need for control of pain and its long-term sequelae during the critical phases of neurologic maturation in the preterm and term newborn. The neonatal pain-control group, as part of the Newborn Drug Development Initiative (NDDI) Workshop I, addressed these concerns. The specific issues addressed were (1) management of pain associated with invasive procedures, (2) provision of sedation and analgesia during mechanical ventilation, and (3) mitigation of pain and stress responses during and after surgery in the newborn infant. The cross-cutting themes addressed within each category included (1) clinical-trial designs, (2) drug prioritization, (3) ethical constraints, (4) gaps in our knowledge, and (5) future research needs. This article provides a summary of the discussions and deliberations. Full-length articles on procedural pain, sedation and analgesia for ventilated infants, perioperative pain, and study designs for neonatal pain research were published in Clinical Therapeutics (June 2005).

Analgesia↗
PubMed2006

[Differentiation of human umbilical cord blood mesenchymal stem cells toward neurons induced by baicalin in vitro].

OBJECTIVE: To study the possibility and mechanism by which the human umbilical blood mesenchymal stem cells (MSCs) are induced to differentiate into neuron in vitro by baicalin, a kind of flavonoid isolated from an important medicinal plant Scutellariae Radix. METHODS: Human cord blood was obtained via sterile procedure with 20 U/ml of preservative-free heparin. MSCs were isolated by the two-step assay of gelatin sedimentation plus Ficoll centrifugation separation, purified and amplified in the liquid culture medium. According to the kind of antioxidants, the experiment was conducted in five groups: induction group, control group I, control group II, control group III and control group IV. Five subgroups of MSCs amplificated ex vivo for 2 weeks in each group were induced by the media containing baicalin (BC, 200 - 400 micromol/L) or baicalin-free for seven days. The media consisted of induction medium (DMEM plus 200 - 400 micromol/L of baicalin) and post-induction medium (DMEM plus 200 - 400 micromol/L of baicalin, B27). The expression of neuronal or glia specific markers was evaluated by using indirect immunofluorescence cytochemistry staining. The percentage of differentiated cells and living cells was measured by Hoechest 33,258 staining assay. RESULTS: After induction for 7 days, MSCs displayed neuronal morphologies, such as pyramidal cell bodies and processes formed extensive network. The undifferentiated cells did not exhibit a neuronal or glial phenotype, while the differentiating cells expressed NSE and MAP-2, the specific markers of neuron, but did not express GFAP, the specific marker of glia on the seventh day after induced by baicalin. The percentage of NSE and MAP-2 expressed on the seventh day after induced by baicalin was (76.3 +/- 9.2)% and (78.5 +/- 5.5)%, respectively, which was significantly higher compared with control group I, control group II and control group III (P < 0.01), respectively. In addition, the ratio of living cells after induced for seven days in the BC group was (85.3 +/- 4.8)%, which increased significantly compared with control group I, control group II and control group III (P < 0.01), respectively. CONCLUSIONS: Baicalin may induce the umbilical blood MSCs to neuron or neuron-alike cells in vitro in a moderate and stable manner. The mechanism of such an induction may be related with its controlling the activity of NF-kappaB which regulates the production of many kinds of cytokines, such as brain-derived neurotrophic factor (BDNF), etc.

Cell Culture Techniques↗
PubMed1989

[Organic dementia among dental technicians. A cross-sectional study of dental technicians with opticians as the control group].

The preparation methyl metacrylate (MMA) an organic solvent which is employed inter alii in the production of prostheses, is regarded as neurotoxic. With the object of illustrating to what extent dental technicians have symptoms compatible with organic dementia as compared with a control group, a cross-sectional questionnaire investigation was undertaken in a population consisting of 256 dental technicians and 160 opticians, all of whom were professionally active. The percentage replies for the two groups were 88 and 85 respectively. The two groups do not differ from one another as regards background variables with the exception of age and adjustments are made for this in the analysis. The results demonstrate that there is a statistically higher prevalence of the majority of acute and also chronic symptoms among dental technicians than among opticians. The symptom pattern and the presence of information and selection bias are discussed and it is concluded that this investigation confirms the hypothesis that symptoms compatible with organic dementia are commoner among dental technicians. The results raise the suspicion that MMA may cause acute and chronic damage to the central nervous system, even after very slight exposure. Revision of the occupational environment of dental technicians, including the current hygienic limits for MMA, is recommended.

Adult↗
PubMed2003

Neuronavigation combined with electrophysiological monitoring for surgery of lesions in eloquent brain areas in 42 cases: a retrospective comparison of the neurological outcome and the quality of resection with a control group with similar lesions.

The purpose of this study was to achieve a more radical resection of tumors in the area of the motor cortex via minimal craniotomy using a combination of neuronavigation and neurophysiological monitoring with direct electrical cortical stimulation and to compare retrospectively the clinical outcome and postoperative magnetic resonance imaging with a control group that was operated on in our service when the combination of these monitoring techniques was not available. A total of 42 patients with tumors in or near the central region underwent surgery with neuronavigation guidance and neurophysiological monitoring. The primary motor cortex was identified intraoperatively by the somatosensory evoked phase reversal method and direct cortical stimulation. The functional areas were transferred into the neuronavigation system. By stimulating the identified primary motor cortex and displaying the motor area in the operating microscope a permanent control of the motor function was possible during the whole operation. Using these techniques a more radical tumor resection - evaluated by postoperative MRI - was achieved in the study group (p = 0.04) and also a trend toward a better neurological outcome.

Adolescent↗
PubMed1998

Psychosocial status of women requesting breast reduction surgery as compared with a control group of large-breasted women.

The breast has special significance for women but unlike women seeking breast augmentation little research has been carried out on those seeking breast reduction. The few studies to date have not used well-recognized instruments nor appropriate controls. The present study compared 33 patients on a waiting list with 22 large-breasted controls using a semistructured questionnaire and well-validated instruments. Patients experienced greater physical and psychological difficulties but similar social difficulties as compared with the control group. Patients were also more anxious and depressed and had poorer self-esteem, body image, interpersonal functioning, and health status. This study confirms the high psychological morbidity of patients seeking breast reduction.

Adult↗
PubMed2002

Phase II randomized multicenter study evaluating a treatment regimen alternating docetaxel and cisplatin-vinorelbine with a cisplatin-vinorelbine control group in patients with stage IV non-small-cell lung cancer: GFPC 97.01 study.

BACKGROUND: The potential absence of cross-resistance between cisplatin and docetaxel in non-small-cell lung cancer (NSCLC) suggests that alternating regimens of cisplatin-based chemotherapy and docetaxel might increase the activity of chemotherapy in stage IV NSCLC. PATIENTS AND METHODS: Randomized, multicenter, non-comparative phase II study in patients with stage IV NSCLC (Eastern Cooperative Oncology Group performance status of 0-2). Patients randomized to alternating treatment group (A) received docetaxel 100 mg/m2 on days (D) 1 and 43 alternating with cisplatin 100 mg/m2 on D22 and vinorelbine 30 mg/m2 on D22, D29 and D36. Those randomized to the control group (B) received cisplatin 80 mg/m2 on D1, D22 and D43 and vinorelbine 30 mg/m2 once a week from D1 to D57. Treatment was continued for a further 6 weeks in the event of objective response or stabilization. RESULTS: Seventy patients were enrolled (group A: 38, group B: 32). More premature treatment discontinuations due to toxicity were observed in group A (median number of cycles: 3) than in group B (median number of cycles: 5). The intention-to-treat objective response rate was 10.8% [95% confidence interval (CI) 0.8% to 20.8%] in group A compared with 25% (95% CI 10% to 40%) in group B, the median time to treatment failure being 10.2 weeks and 17.3 weeks, respectively. The median survival and 1-year survival were 29.1 weeks and 39% in group A compared with 41.6 weeks and 42% in group B. Febrile neutropenia occurred in 5.9 and 4.9% of the cycles in group A and group B, respectively. Non-hematological toxicity was moderate in the two groups. CONCLUSIONS: The addition of docetaxel alternating with cisplatin-vinorelbine did not enhance the activity of this combination. The development of sequential regimens might be a more promising way of exploiting the absence of cross-resistance between these two drugs.

Adult↗
PubMed1994

[Intensive back exercises 5 weeks after surgery of lumbar disk prolapse. A prospective, randomized multicenter trial with a historical control group].

An intensive, dynamic rehabilitation program applied to patients who had undergone first time lumbar discectomy was evaluated in a multicentre, clinical trial. Ninety-six patients between 18 and 70 years of age who had been operated within the period September 1989 to May 1990 at the Department of Neurosurgery, Copenhagen County Hospital, Glostrup were consecutively randomized into one of two rehabilitation programs: a) traditional mild, general mobility-improving exercises within pain limits; or b) intensive dynamic back extension and abdominal exercises without low back pain being the limiting factor. Both groups underwent 14 hours of treatment over a period of six weeks, starting five weeks after surgery. Seventy-six patients operated within the period January 1989 to September 1989 formed the historical control group. The results at follow-up at 26 weeks favoured intensive exercises with regard to the patients disability-index and working capabilities. The results are statistically significant. After one year a trend favouring intensive exercises can be observed. No differences in pain or objective measurements were found. A rehabilitation program using intensive exercises without back pain being the limiting factor appears to give the patients increased behavioural support, resulting in improvements in work capacity and reduction in patients' self-rated disability.

Adolescent↗
PubMed1978

[The etiology of epilepsies in children by considering the case histories in comparison with a control group (author's transl)].

To clarify the etiology of epileptic illnesses in children a detailed questionnaire was prepared, with questions on both genetic factors and the possibility of pre-, peri- and postnatal injury. The questionnaire was filled out by the parents of 422 epileptic children and those of 150 healthy control children of the same age. The differences were statistically calculated by means of the x2 test, small values being corrected according to Yates. Hereditary factors were found in 10.2% of all patients, ranging from 5.6% to 13.5% for the various seizure types (control group:0.6%). A high rate of hereditary afflictions was found even in those types of seizure which are considered predominantly symptomatic (salaam [West] or myoclonic-astatic convulsions: 13.5%, focal attacks: 11.2%). The significance of some exogenic factors, e.g. illnesses during pregnancy, prematurity, birth complications, was statistically confirmed in some instances for all types, in other instances only for certain types of seizure. As regards other factors, however, whose causative role has hitherto been considered proven or at least very probable, no differences were found between patients and controls (e.g. protracted labor, uterine inertia, coiling of the umbilical cord). Confirmation was found for the generally accepted rule that exogenic injuries are most often demonstrable in children with salaam or myoclonic-astatic convulsions and least often in those with absences. In conclusion, it is emphasized that an absolute dividing line can no longer be drawn between genetic and symptomatic epilepsies; in many cases the exogenic influence merely serves as a touching-off factor for a gentic epilepsy.

Adolescent↗
PubMed2000

A study to investigate the prevalence, severity and correlates of fatigue among patients with cancer in comparison with a control group of volunteers without cancer.

BACKGROUND: Determining the prevalence of fatigue among cancer patients is complicated by the high prevalence of fatigue symptoms in the general population. The aim of this study was to determine the prevalence, severity and correlates of fatigue among both cancer patients and control subjects without cancer. PATIENTS AND METHODS: A total of 227 cancer patients and 98 control subjects were recruited to the study. They completed a number of questionnaires about fatigue, quality of life and psychological symptoms. The majority of subjects also underwent assessment of voluntary muscle function and nutritional status. Severe fatigue in the patients was defined as a score on the Fatigue Severity Scale in excess of the 95th percentile of the control group. RESULTS: The prevalence of severe fatigue was 15% among patients with recently diagnosed breast cancer, 16% among patients with recently diagnosed prostate cancer, 50% among patients with inoperable non small cell lung cancer and 78% among patients receiving specialist inpatient palliative care. In the patients a combination of dyspnoea, psychological distress, pain, and a measure of overall disease burden accounted for 56% of the variance in fatigue scores. CONCLUSIONS: Severe fatigue is a common problem among cancer patients, particularly those with advanced disease. Fatigue is significantly associated with the severity of psychological symptoms (anxiety and depression) and with the severity of pain and dyspnoea.

Adult↗
PubMed2000

Electroencephalographic coherence in Alzheimer's disease: comparisons with a control group and population norms.

Previous research from independent laboratories has shown reduced electroencephalographic coherence in patients diagnosed with dementia of the Alzheimer type (DAT). This study added to this work by comparing interhemispheric and intrahemispheric coherence in nonmedicated DAT patients (n = 35) with that of a normal control group (n = 30), as well as with a data bank of population norms. Raw and Z-score transformed values showed reduced coherence, interhemispherically (in delta, theta, alpha, and beta bands) and intrahemispherically (delta and theta bands) in DAT patients with both comparison procedures. Discriminant analysis correctly classified 73% to 75% of patients. The results are discussed in relation to earlier research, "trait" versus "state" factors, the cholinergic system, and cognitive processes in dementia.

Aged↗
PubMed2001

Contribution of Doppler echocardiography to the evaluation of systolic and diastolic function of obese women versus a control group.

OBJECTIVE: To study by doppler echocardiography the cardiac systolic and diastolic functions of health, uncomplicated obese subjects. METHODS: Fifty-nine obese women with an average body mass index (BMI) of 35 kg/m2 were evaluated and compared with 19 subjects with an average BMI of 23 kg/m2 (control group). RESULTS: In the obese group, a clear tendency was observed toward higher systolic pressure, increased wall thickness and, consequently, myocardial mass, elevation on the circumference stress of the left ventricular wall, and an indisputable presence of diastolic abnormalities. Filling abnormalities were observed with impaired relaxation, with prolonged isovolumic relaxation time (IVRT) and augmented atrium contribution representing early indexes of cardiac dysfunction when systolic performance is still normal. CONCLUSION: Obesity is generally a chronic condition, and doppler echocardiography can be used as a noninvasive instrument for early evaluation of left ventricular diastolic indexes.

Adult↗